Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema

Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02399514

Enrollment

Registered

2015-03-26

Start date

2014-11-05

Completion date

2018-03-09

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Emphysema

Keywords

Sleep, emphysema, coils, lung volume reduction

Brief summary

Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema. Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after. Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment. Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).

Interventions

OTHERPolysomnographic diagnostic

Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written consent * RePneu Coil treatment according to clinical criteria

Exclusion criteria

* Pregnancy or nursing period * Participation in another clinical trial within the last 4 weeks * Incapable of giving consent * Known OSA (AHI\>10)

Design outcomes

Primary

Measure	Time frame	Description
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.	3 times in one year	Sleep Efficiency is evaluated by the ratio of WASO (Time wake after sleep onset) to Sleep Period Time (SPT).

Secondary

Measure	Time frame	Description
Quality of life Questionnaire	3 times in one year	The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.

Other

Measure	Time frame
Activity: Physical activity measured by an actimeter over 7 days, before and 6 month after the coil treatment. The device is able to capture activity levels, sleep and wake times .	1 week in baseline and 6 month after coil treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026